QuantumCam

FDA UDIEUDAMED

Class II (US FDA UDI)

by Ddd-Diagnostic A/S

Identity

Trade Name: QuantumCam FDA UDI
Generic Name: Stationary gamma camera system FDA UDI
Device Name: Gamma Camera System FDA UDI
Model / Reference: QuantumCam Gamma Camera System FDA UDI
Description: Gamma Camera System FDA UDI

Identifiers

Catalog Number: 9SYS2070 FDA UDI
Primary DI / UDI-DI: 05711665003002 FDA UDI
510(k) Number: K140206 FDA UDI
FDA Product Code: KPS FDA UDI
GMDN Term: Stationary gamma camera system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 2144 Kilogram FDA UDI
Height — 225 Centimeter FDA UDI
Depth — 197 Centimeter FDA UDI
Width — 291 Centimeter FDA UDI

Category: Stationary gamma camera system

QuantumCam by Ddd-Diagnostic A/S — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Cleared under the same submission

K140206 also covers:

BodyMD — Ddd-Diagnostic A/S

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ddd-Diagnostic A/S

Sources (2)

FDA UDI 942da5a4-f378-40a1-af25-e8cdf04ddfc3 37 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 3, 2026